An observational study in Infective Endocarditis and Valvular Heart Disease, sponsored by Jena University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-24.
Sponsored by Jena University Hospital · Observational
The study aims at the comparative examination of pre-, intra- and post-operative release profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery under cardiopulmonary bypass (CPB) due to either infectious endocarditis or degenerative valvular heart disease. Specific attention will focus on the distinction between mediator release associated with infection and that resulting from CPB. Concomitantly identification and characterization of infectious pathogens in the circulation and in valvular samples will be carried out, together with the search for resistance-coding transcripts.
Exaggerated release of inflammatory mediators and endogenous vasoactive substances resulting from the coincident infection and surgical stress plays a role in post-operative organ failure and altered immune defense, thus contributing to unfavorable post-operative outcome.
Cardiopulmonary bypass (CPB) itself, even in the absence of IE, has been shown to modify cytokine and vasoactive mediator release and may cause organ failure. Tracing of release profiles of inflammatory cytokines and vasoactive mediators and their correlation with postoperative organ dysfunction in cardiac surgery for IE or non-IE patients aims at the assessment of the prognostic validity of these biomarkers and the evaluation of measures for their pro-active clearance during the surgical intervention.
Induction of inflammatory mediators and their temporal release profile may vary depending on the involved pathogens, which cannot be always identified by conventional techniques (blood culture). Since it is conceivable that identification of the involved pathogen could explain differences in cytokine secretory patterns in IE, use of advanced molecular technologies (NGS) will support the clarification of such relations. Analysis of transcripts encoding inflammatory and vasoactive mediators in blood cells will enable the surveillance of temporal oscillations in their profiles during the observation time frame. Transcriptome analysis of identified putative pathogens can also disclose features of antibiotic resistance.
85 studies on the registry are indexed under Endocarditis, Bacterial; 19 are open to participants now.
This study's enrollment of 40 is below the median of 196 across 46 observational studies indexed under Endocarditis, Bacterial.
Browse Endocarditis, Bacterial studies →Jena University Hospital is the lead sponsor of 62 studies on the registry; 19 are open to participants now.
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Patients diagnosed with infective endocarditis or valvular heart disease, undergoing cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
Blood sample collection and assessment of signs of organ dysfunction in patients diagnosed with infective endocarditis in accordance with Duke criteria and scheduled for valve surgery
Procedure: Blood sample collection · Other: Assessment of signs of organ dysfunction
Blood sample collection and assessment of signs of organ dysfunction in patients diagnosed with valvular heart disease, with no signs of infection, scheduled for valve replacement surgery
Procedure: Blood sample collection · Other: Assessment of signs of organ dysfunction
Drawing of 10 ml blood at inclusion, at the time of CPB connection, 60 min under CPB, at the time of CPB disconnection, 6, 24 and 48 hours post-surgery
Assessment of signs of organ dysfunction based on medical data prior to surgery, 24 and 48 hours post-surgery, and at the time of ICU discharge
Also known as: SOFA score
Area under the plasma concentration versus time curve (AUC) of Procalcitonin
Plasma levels of Procalcitonin over time
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of C-reactive Protein (CRP)
Plasma Levels of CRP over time
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Endothelin 1
Plasma Levels of Endothelin 1 over time
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Tumor Necrosis Factor (TNF) alpha
Plasma Levels of TNF alpha over time
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 1beta
Plasma Levels of IL 1beta over time
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 6
Plasma Levels of IL 6 over time
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 10
Plasma Levels of IL 10 over time
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 18
Plasma Levels of IL 18 over time
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of pro-Adrenomedullin
Plasma Levels of pro-Adrenomedullin
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of pro-Arginine vasopressin
Plasma Levels of pro-Arginine vasopressin
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
Area under the plasma concentration versus time curve (AUC) of pro-Atrial natriuretic peptide
Plasma Levels of pro-Atrial natriuretic peptide
Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery
SOFA Score
Changes in SOFA scores after surgery, as compared to pre-surgery baseline
Time frame: 24 h before and 24 and 48 h after surgical intervention
Renal replacement therapy
Use and duration of renal replacement therapy
Time frame: Over 7 days following surgery
Concomitant medication
Cumulative doses of applied vasopressors, corticosteroids and prostaglandins
Time frame: During and 48 h upon completion of surgical intervention
In-hospital mortality
Post-surgical mortality over 30 days
Time frame: 30 days after surgery
Pathogen genotyping
Identification of circulating pathogens
Time frame: Before and during intervention at the heart valve
Resistance transcripts
Abundance of bacterial transcripts encoding antibiotic resistance in blood
Time frame: During intervention at the heart valve
Plan to share: No
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Jena University Hospital